Specialist pharmaceuticals group Vectura Group (LON:VEC) saw its shares soar more than 14% to 38p this morning on news that it was set to land a $7.5m milestone payment from drugs giant Novartis. The windfall has been triggered by confirmation that Phase III clinical trials are set to get underway on Vectura's flagship candidate for the treatment of chronic obstructive pulmonary disease (COPD).

The programme will see Novartis launch two 52 week studies using QVA149, a once-daily, dry powder bronchodilator for inhalation combining a fixed dose of the once-daily beta2-agonist QAB149 (indacaterol) and the long-acting muscarinic antagonist NVA237 (glycopyrronium bromide). The first trial, a randomised, double-blind, parallel-group design, will assess as its primary outcome measure the superiority of QVA149 over NVA237 alone in the rate of exacerbations in 1,998 patients with severe or very severe COPD from study centres across the US, Europe and other territories. Secondary endpoints include time to first exacerbation together with safety and tolerability. The second trial has a randomised, double-blind, parallel-group, placebo controlled design and will assess the long term safety and tolerability of QVA149 in 339 patients with moderate to severe COPD. 

NVA237 was licensed to Novartis by Vectura and its co-development partner Sosei Group Corporation in a 2005 deal in which the two companies could receive up to US$375m in milestones as well as royalties on product sales. Phase III trials on NVA237 commenced in June 2009 and Novartis has stated that it expects to file for approval in 2011. Novartis received European regulatory approval for indacaterol (Onbrez® Breezhaler® - indacaterol maleate) in November 2009 and launched the product in Germany in December 2009 and in Ireland and Denmark in March 2010 and have confirmed that they are on track to file the additional data requested by the Food and Drug Administration (FDA) in the second half of 2010.

Dr Chris Blackwell, the chief executive of Vectura, said: "The data from the two Phase II QVA149 studies presented at the annual congress of the European Respiratory Society (ERS) in Vienna in September 2009 were very encouraging and demonstrated the benefit of combining two potent bronchodilators in a convenient once-daily therapy with an attractive efficacy and safety profile. This is the first once daily LAMA/LABA combination product to enter Phase III trials and, with an anticipated filing date of 2012, could provide an important…

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